(36 days)
Not Found
Not Found
No
The summary describes a standard medical glove and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device, "Nitrile Powder Free Patient Examination Gloves," is intended to prevent contamination between healthcare personnel and patients. This function is preventative and protective, not therapeutic, as it does not treat or cure a disease or condition.
No
Explanation: The device is described as "Nitrile Powder Free Patient Examination Gloves" used to prevent contamination, which is a protective function rather than a diagnostic one.
No
The device description clearly states "Nitrile Powder Free Patient Examination Gloves," which are a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a "Nitrile Powder Free Patient Examination Gloves" and its intended use is to be "worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient."
- Lack of Specimen Analysis: The device does not involve the analysis of any specimens taken from the human body. It is a barrier device used externally.
Therefore, based on the provided information, this device falls under the category of a medical device, but specifically a Class I or Class II medical device (depending on the specific regulations and risk classification), not an IVD.
N/A
Intended Use / Indications for Use
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Product codes
LZA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling a bird in flight, composed of three curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1997
Derlin Company Ltd. C/O Mr. John Bucher Official U.S. Correspondent 1601 Henry Place Waukegan, Illinois 60085
Re : K974223 Nitrile Powder Free Patient Examination Trade Name: Gloves Requlatory Class: I Product Code: LZA October 8, 1997 Dated: Received: November 12, 1997
Dear Mr. Bucher:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Bucher
through 542 of the Act for devices under the Electronic chrough Sra or on notrol provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predication of mits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on compreates as (advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaration Chorifical (21 CFR 807.97) -Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachmet I
Indication For Use Statement
K914223 510k Number (if known):_ Device Name: Nitrile Powder Free Patient Examination Gloves Indications For Use:
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
DERLIN CO.,LTD
Gily S. Peri
EDDY D LIOU
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Division Sign-Off | |
|---|---|
| Division of Dental, Infection Control and General Hospital Devices, Office of Device Evaluation (ODE) | |
| 510(k) Number | K974223 |
| Prescription Use | OR Over-The-Counter Use X |
(Optional Format 1-2-96)